| CTRI Number |
CTRI/2025/01/079300 [Registered on: 23/01/2025] Trial Registered Prospectively |
| Last Modified On: |
17/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Other (Specify) [premature oral motor intervention] |
| Study Design |
Other |
|
Public Title of Study
|
A study to compare the effectiveness of Premature Infant Oral Motor Intervention versus routine care on oral feeding readiness among preterm neonates |
|
Scientific Title of Study
|
Effectiveness of Premature Infant Oral Motor Intervention on oral feeding readiness among preterm neonates-A randomized controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Not applicable |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Meenu Chandran J |
| Designation |
PG Nursing student |
| Affiliation |
Government College of Nursing Thiruvananthapuram |
| Address |
Government College of Nursing
Thiruvananthapuram
Child Health Nursing Department
Kerala
Thiruvananthapuram KERALA 695011 India |
| Phone |
6238970159 |
| Fax |
|
| Email |
meenuchandranmjm@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Meenu Chandran J |
| Designation |
PG Nursing student |
| Affiliation |
Government College of Nursing Thiruvananthapuram |
| Address |
Government College of Nursing
Thiruvananthapuram
Child Health Nursing Department
Kerala
Thiruvananthapuram KERALA 695011 India |
| Phone |
6238970159 |
| Fax |
|
| Email |
meenuchandranmjm@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Sreeja SA |
| Designation |
Assistant Professor |
| Affiliation |
Government College of Nursing Thiruvananthapuram |
| Address |
Government College of Nursing
Thiruvananthapuram
Pediatric Nursing Department
Kerala
Thiruvananthapuram KERALA 695011 India |
| Phone |
8547475708 |
| Fax |
|
| Email |
sreejaajith@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Meenu Chandran J |
| Address |
Government College of Nursing
Thiruvananthapuram
Kerala
695011 |
| Type of Sponsor |
Other [self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Sreeja S A |
Government Medical college HOSPITAL THIRUVANANTHAPURAM |
Neonatal intensive care unit Thiruvananthapuram KERALA |
6238970159
sreejagajith@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee government college of nursing medical college Thiruvananthapuram constituted as per order no.A4/1579/2011/CNT dtd 21/7/2011 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R69||Illness, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Premature Infant Oral Motor Intervention |
Efficacy of Premature Infant Oral Motor Intervention on Oral feeding readiness among preterm neonates
Duration of intervention 3 times per day total 14 days |
| Comparator Agent |
Routine care given to the control group |
Compare the effectiveness of premature infant oral motor intervention versus routine oral massage on oral feeding readiness among preterm infants
Duration 14 days |
|
|
Inclusion Criteria
|
| Age From |
7.00 Month(s) |
| Age To |
8.00 Month(s) |
| Gender |
Both |
| Details |
Preterm neonates born between 29 to 32 weeks of gestation
Preterm neonates who are haemodynamically stable
|
|
| ExclusionCriteria |
| Details |
Neuromuscular disorder
Chromosomal anomaly
Craniofacial malformmation
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of Premature Infant Oral Motor Intervention on oral feeding readiness among preterm neonates |
The outcome will be assessed 7th and 14th day of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Not applicable |
Not applicable |
|
|
Target Sample Size
|
Total Sample Size="60" Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Title
Efficacy of Premature Infant Oral Motor Intervention
on Oral feeding readiness among preterm neonates – A randomized controlled
trial Objective of the study
= To
determine the efficacy of Premature Infant Oral Motor Intervention (PIOMI) on
oral feeding readiness among preterm neonates admitted in Neonatal Intensive
Care Unit. FoFormal permission for data collection will be obtained from Institutional Research
Committee, Institutional Ethics committee, Medical Superintendent SAT Hospital
Thiruvananthapuram and Head of the department, Neonatology. After getting
informed consent from the parents investigator will select preterm neonates
admitted in NICU who meet the eligibility criteria for the study and will be
randomly allocated in to experimental and control group. The samples will be
allocated equally by using block randomization with fixed block size of 4 in to
two groups, experimental and control group. The preterm neonates in the
experimental group will receive PIOMI for 15 minutes before the gavage feed,
along with the routine nursing care 2 times daily using aseptic precautions.
This process will be continued for maximum 14 days, when the baby reaches
feeding readiness whichever is earlier. The control group will also receive
routine care during the 14 days of the study. Both groups will be assessed from
the 4th day onwards till the achievement of oral feeding readiness.
(POFRAS score >30)
|